BioPoly® Receives CE Mark for Shoulder
FORT WAYNE, IN – BioPoly LLC has announced that it has received CE mark certification for its BioPoly® RS Partial Resurfacing Shoulder System, expanding the BioPoly implant technology to the humeral head. The BioPoly® RS resurfacing technology takes advantage of its proprietary material which is designed to interface with orthopaedic tissues such as cartilage, meniscus, and labrum; therefore, the BioPoly® RS Partial Resurfacing Shoulder Implant replaces only the damaged portion of the joint surface as opposed to the entire joint.
The BioPoly® RS Shoulder is similar to the BioPoly® RS Partial Resurfacing Knee which has been used clinically in Europe and parts of Asia since 2012 and is having excellent outcomes. Like the knee, the BioPoly shoulder is minimally invasive and tissue sparing. “I am thrilled that our BioPoly® RS Shoulder products have been granted the CE mark. They complement our already successful knee and patella product lines and now provide shoulder surgeons with a partial resurfacing option with a cartilage-friendly implant,” said Herb Schwartz, Ph.D., President of BioPoly. According to the Company, the BioPoly® RS Partial Resurfacing Shoulder will be launched in the European markets in the very near future.
BioPoly® combines a polymer (ultra-high molecular weight polyethylene or UHMWPE) with a molecule found in joint fluid, hyaluronic acid, thus, creating a “self-lubricated” polymer. The end result is that BioPoly® is compatible with native tissues such as cartilage and meniscus because it attracts lubricating fluid to its surface, similar to native cartilage. Thus, BioPoly implants can be used to repair the damaged cartilage (i.e. partially resurface) in joints. Although the BioPoly® family of partial resurfacing products (RS Knee, RS Patella, and RS Shoulder) are CE marked, they have not yet been approved for use in the US.
About BioPoly LLC
BioPoly LLC is an ISO 13485 certified orthopaedic implant manufacturer located in Fort Wayne, Indiana. The Company is developing, manufacturing and marketing products for use in sports medicine, orthopaedics, and spinal markets. Additional medical applications of the BioPoly® technology in cardiovascular and trauma markets are also being pursued.